Follow-up report #1 is to provide fda with missing information, new information, and changed information.New information: device was returned to rwmic and evaluation was conducted, (b)(6) 2020, using visual and functional testing.The reported condition - device when inserted into the patient fell apart: was confirmed during evaluation.The probable root cause is reprocessing and user error.Findings of the investigation conclude that the shaft of the scope was damaged due to reprocessing and the head damaged by laser.Changed information: the following fields have changed information: b5, d10, f1, g7, h6, h7, and h10.Device labeling was reviewed for patient code and device codes, see below: patient code: not applicable, no patient problem was reported.Device code: ifu was reviewed.The ifu contains cautions and warnings about using the device.The ifu also contains handling instructions during reprocessing.Caution! failure to observe can result in slight injury or damage to the product.Important: failure to observe can result in damage to the product or surroundings high temperatures due to highly coherent laser beam! the heat generated by the laser beam reduces the strength of instrument parts.Do not direct the laser beam at instrument parts, in particular not at plastic parts.Keep a safe distance.Danger of destroying the instrument by laser energy! important general notes and instructions: use the product only in the combinations and with the accessories and spare parts specified in this instruction manual.Use other combinations, accessories and replacement parts only if they are expressly intended for the planned application and if the performance characteristics and safety requirements are not impaired.Do not alter the product in any way.Handling during reprocessing: safe storage and transport of the endoscope to the reprocessing room in a closed container to prevent damage to the endoscope and contamination of the environment.Rwmic considers this mdr closed.Follow-up reports will be sent to the fda if new information is received.Attachment: [ga-d347 usa_7.0 (13-0236).Pdf, ga-j050 usa_5.0 (13-0221).Pdf].
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